SEAPOSTAR ® MODEL – CZF HIFU device is used for non-invasive treatment of some of the most frequent gynecological diseases of the UTERINE CERVIX and the VULVA.
SEAPOSTAR ® MODEL – CZF provides an organ-sparing and harmless clinical approach that replaces the conventional surgical treatment.
INDICATIONS (diseases):
Symptomatic ectopia of the uterine cervix
Cervicitis (inflammation of the uterine cervix)
HPV-infection
Non-neoplastic intraepithelial lesions of the vulva (vulvar dystrophies):
Lichen sclerosus
Squamous cell hyperplasia
Vulval condyloma acuminatum
ADVANTAGES OF HIFU OVER THE STANDARD METHODS OF TREATMENT:
A completely non-invasive method - no surgical excisions, scars and other changes on the skin and the mucosa - high-intensity focused ultrasound (HIFU) penetrates deeply but the skin and mucosa are absolutely intact and preserved.
an organ-sparing procedure - femininity is spared, self-confidence and quality of life are significantly improved
Efficiency – after the treatment of the diseases by the- high intensity focused ultrasound (HIFU) no recurrences are observed.
Accuracy - HIFU eliminates only and precisely the tumor cells in the body, without affecting the surrounding tissues and the normal functions of the body
Monitoring the impact of treatment in real time
Absolutely safe and harmless method
CHARACTERISTICS OF THE DEVICE SEAPOSTAR ® MODEL-CZF:
The focal length is short and easy for manipulation
It is suitable for various treatment targets, because the components are flexible and the parameters are adjustable
Monitoring is in real time
Targeting is non-invasive and accurate
Optimized clinical protocols and standards are used
N.B. According to the medical records, the symptoms are improved in 95% of the cases treated by SEAPOSTAR ® MODEL-CZF
Haifu® Model JC is a unique therapeutic system for non-invasive extracorporeal treatment of benign (not cancerous) and malignant (cancerous) tumors through the use of High-Intensity Focused Ultrasound (HIFU), which is not only the first of its kind in the world but the first CE marked extracorporeal therapeutic system for malignant- tumor - treatment in the world.
How does it work?
HAIFU ® Model-JC has its own computer software to merge CT (MRI) imaging with ultrasound images. This ensures maximum precision for the doctor and security and safety for the patient.
HAIFU ® Model-JC integrates optimized planning, real-time image guidance and high-intensity focused ultrasound (HIFU) energy deposition in the target zone of the tumor. The power can reach 25,000 W/cm² in the focused area, which increases the temperature there (> 60°C) to cause tumor necrosis (death of the tumor cells) without affecting any of the surrounding tissue.
HAIFU ® Model-JC is the ultrasound guided therapeutic system which allows the physician to adjust the orientation, position and intensity of the ultrasound beam in real time according to the observed image of the target area.
The target area with tissue cells that have to be destroyed can be as small as 1,1 mm x 3,3 mm. The precise linear motion system (deviation: ± 1 mm) ensures that only and exactly this area will be treated. The system provides the physician with a very precise "invisible knife” – the ultrasound. It ablates tumors while preserving healthy tissue.
In most malignant tumors, though, 10-15 mm of the surrounding healthy tissue has to be ablated in order to obtain a complete and secure ablation with a radical resective line of the tumor.
What kinds of tumors can be treated with HAIFU ® Model-JC Therapeutic System?
HIFU can treat benign (not cancerous) tumors:
Uterine fibroids (myoma)
Breast Fibroadenoma
Adenomiosis (uterine disease)
HIFU can complement the standard treatment of malignant solid (cancerous) tumors of:
Pancreas
Liver – HCC (Hepatocellular Carcinoma) and Liver metastases
Breast
Soft tissues
Kidney
HIFU can be used as:
a pain relief palliative treatment of advanced malignancy
as a treatment of tumors in difficult for conventional surgery position
as a treatment of recurrent tumors after conventional surgery
SEAPOSTAR ® MODEL – CZF HIFU- DEVICE
Description:
SEAPOSTAR ® MODEL – CZF HIFU device is used for non-invasive treatment of some of the most frequent gynecological diseases of the UTERINE CERVIX and the VULVA.
SEAPOSTAR ® MODEL – CZF provides an organ-sparing and harmless clinical approach that replaces the conventional surgical treatment.
INDICATIONS (diseases):
Symptomatic ectopia of the uterine cervix
Cervicitis (inflammation of the uterine cervix)
HPV-infection
Non-neoplastic intraepithelial lesions of the vulva (vulvar dystrophies):
Lichen sclerosus
Squamous cell hyperplasia
Vulval condyloma acuminatum
ADVANTAGES OF HIFU OVERTHE STANDARD METHODS OF TREATMENT:
A completely non-invasive method - no surgical excisions, scars and other changes on the skin and the mucosa - high-intensity focused ultrasound (HIFU) penetrates deeply but the skin and mucosa are absolutely intact and preserved.
an organ-sparing procedure - femininity is spared, self-confidence and quality of life are significantly improved
Efficiency – after the treatment of the diseases by the- high intensity focused ultrasound (HIFU) no recurrences are observed.
Accuracy - HIFU eliminates only and precisely the tumor cells in the body, without affecting the surrounding tissues and the normal functions of the body
Monitoring the impact of treatment in real time
Absolutely safe and harmless method
CHARACTERISTICS OF THE DEVICE SEAPOSTAR ® MODEL-CZF:
The focal length is short and easy for manipulation
It is suitable for various treatment targets, because the components are flexible and the parameters are adjustable
Monitoring is in real time
Targeting is non-invasive and accurate
Optimized clinical protocols and standards are used
N.B. According to the medical records, the symptoms are improved in 95% of the cases treated bySEAPOSTAR ® MODEL-CZF
HIFU is an acronym meaning “High-Intensity Focused Ultrasound”.
Why the HIFU treatment is so popular?
The therapy with HIFU (Ultrasound ablation) is a revolutionary, radically new approach to the treatment of solid tumors in the human body - both benign and malignant. The method became very popular among patients and doctors, and is widely used in the world's leading clinical centers in recent years. It is completely non-invasive extra-corporal medical treatment where a high-intensity focused ultrasound beam is applied with unique precision in the target zone of the tumor and thus ablation (destruction) of the non-cancerous, pre-cancerous or cancerous neoplasms is obtained. HIFU therapy is organ-sparing, without conventional surgical excision - no scars, no blood-loss, with minimal risk of infection and lack of operational stress. It is important to point out that the patient recovers in 24 hours and may return to her/his active routine 1-2 days after the procedure.
HIFU therapy
First in Eastern Europe International HIFU Conference
The consultation and examination by the doctors at the “Saint Marina” HIFU-Center (the team includes a Professor of Oncology), certified to work with the HIFU therapeutic system JC and CZF Ultrasound therapeutic device are to establish whether the patient/tumor is appropriate for the HIFU treatment.
* The patient has to present the current CT scans or CD/plaques from MRI examination and all available medical documentation, relevant to his/her case.
** In cases where the patient is referenced by a physician, familiar with the HIFU-criteria, who has assessed the patient as appropriate for this therapy, step 1 could be skipped and the planning– step 2, could be scheduled.
Planning
When it is confirmed that the patient has the indications which make the HIFU-therapy the optimal choice of treatment, a planning of the procedure is performed. This is a “simulation” of the HIFU procedure and includes examination with the ultrasound, diagnostic system and software of the JC system.
N.B. It is obligatory that the patient’s CT scans/ MRI examination results be presented at this stage.
*Exclusively for the patients of the “Saint Marina” HIFU-Center , a partnering hospital provides express MRI examination in the morning of the day of the planning.
You can receive more information on our lines: (+359) 064 90 20 33 and 064 90 20 44.
Treatment
breast fibroadenoma, uterine fibroids, malignant tumors, metastases andpalliative treatment
When the planning confirms that the patient is appropriate for the HIFU therapy, the day for the treatment is scheduled. A preliminary consultation with the anesthesiologist and internist, as well as an ECG examinationis included in the overall treatment price.
Follow-up Examinations
Depending on the indications, the patient could leave the HIFU-Center a few hours after the therapy or - the next day.
The patient is advised to continue with follow-up examinations with the HIFU-specialists. The follow-ups are carried out in 1, 3, 6, 12, 24 months after the HIFU procedure.
Indications for HIFU in primary liver cancer - hepatocellular carcinoma (HCC):
Histologically verified HCC
Assessment of inoperability after consultations with two independent liver surgeons
The tumor is visualized by ultrasound – it is focal form with clear boundaries
Possibility of radical therapy in the first stages of the disease. When the disease is advanced - local palliative treatment with HIFU can be applied
Combination of TAE + HIFU in cases with hypervascular infiltrative process
Application of HIFU in cases of multifocal hepatocellular cancer - with up to 4 nodular foci
The distance between the skin surface and the farthest margin of the tumor is not more than 12 cm
The acoustic path of the FUS is safe and without obstructions
Good general condition of the patient - > 70% by Karnofsky’ scale
Contraindications for HIFU in hepatocellular carcinoma:
Diffuse hepatocarcinoma
The tumor infiltrates more than 50% of the liver
Seriously decompensated liver function
A patient with cachexia and presence of distant metastases Infected liver foci
Class "C" by the scale of Child
Thrombosis / tumor emboli / of the vena cava inferior
Prothrombin time <50%
INDICATIONS FOR HIFU IN SECONDARY LIVER TU / METASTASES / :
Histologically verified malignancy
A contrast enhanced CT study or visualized with abdominal ultrasound liver foci
Liver lesions are inoperable with the conventional surgery ( infiltration into large vessels , multi- centric metastases etc.).
Assessment of inoperability after consultations with two independent liver surgeons
A signed written refusal of the patient for a conventional surgical operation
At least two courses of chemotherapy are applied according to the specifics of the underlying disease
Expected survival for more than 3 months
HIFU ablation is an alternative method for the palliative treatment of liver metastases which may be applied under the following conditions : the number of metastases in the liver is not more than 3-4 , they are not larger in size than 5 cm , the total amount does not exceed 10 cm
CONTRAINDICATIONS FOR HIFU ABLATION OF LIVER METASTASES :
the metastatic process is spread in more than 50% of the liver
More than 4 metastatic foci; larger than 5 cm or the total amount of their size is exceeding 10 cm
Fibroadenomas are the most common benign (not cancerous) tumors of the breast, composed of fibrous and glandular tissue .It mainly affects girls and women between 15 and 35 years of age. In 90% of the cases the neoplasm affects only one breast, in 9.3% this can be in both breasts, while in 9.4% there could be multiple lumps.
The standard method to remove fibroadenomas is by surgical operation, while the patient is under anesthesia and stays in hospital for at least 1 day. After this operation a scar / scars are usually left and they are often the cause of breast deformation.
The modern medicine, however, offers a completely new, non-invasive treatment of fibroadenoma - by using high-intensity focused ultrasound (HIFU).
The HIFU-center to the St. Marina Hospital in Pleven, Bulgaria, for the first time in Eastern Europe offers this modern, non-invasive and patient-friendly method.
ADVANTAGES OF HIFU OVERTHE STANDARD METHODS OF TREATMENT:
100% non-invasive procedure – no surgical excisions
No scars left on the breast
Does not cause a deformation to the breast
Does not require general anesthesia. During the procedure, the patient is only lightly sedated.
No blood loss and risk of infection
It is a completely harmless (non-ionizing) procedure for the patients, doctors and the environment
It is out-patient procedure - no hospitalization is required. The treatment usually lasts for about 40 minutes and the patient can leave the hospital several hours after it.
N.B. To qualify for HIFU treatment, the fibroadenoma must:
Myoma uteri is one of the most common diseases of women in reproductive age. The symptoms are: heavy menstrual bleeding, frequent and painful menstruation, discomfort in the pelvis, secondary anemia and infertility.
Usually the patient is diagnosed with uterine fibroids by the ultrasound examination. Sometimes uterine fibroids are detected incidentally in patients without symptoms at the time of the medical check-ups.
The traditional treatment of uterine fibroids is surgical (invasive or minimally invasive):
Conventional Myomectomy (surgical removal of the uterine fibroids through abdominal access – open surgery)
Laparoscopic Myomectomy (minimally invasive surgery through small cuts on the abdomen)
Histeroskopic Myomectomy (minimally invasive procedure with vaginal access, which is only suitable for sub mucosal fibroids);
ADVANTAGES OF THE HIFU TREATMENT OVER STANDARD METHODS
The HIFU treatment is the completely new extracorporeal (without surgical excision and scars on the skin) approach to the treatment of uterine fibroids. This is a 100 % non-invasive and organ-sparing procedure which does not require general anesthesia; there is no blood loss and postoperative stress.
It is very important that the HIFU procedures are completely harmless (non-ionizing) for the patient, the doctor and the environment. Nowadays HIFU treatment of myoma uteri is the first choice of modern women around the world – it is the uterus (womb) and, respectively, fertility sparing treatment and the recovery is fast and easy - within 1-2 days the woman can return to her usual routine and active lifestyle.
It is expectedthat the extracorporeal ultrasound ablation (HIFU) would become the most popular and most frequently practiced non-invasive treatment of uterine fibroids globally!
SUMMARY OF THE ADVANTAGES OF MYOMA TREATMENT WITH HIFU
100 % non-invasive procedure – there are no incisions and cuts on the skin
Uterine sparing treatment
Woman’s fertility is preserved
Does not require general anesthesia
No blood loss
Harmless and “green” treatment - a non –ionizing procedure for the doctor, the patient and the environment
Fast recovery of the patients – 1-2 days
Out-patient treatment – the patients can go home after HIFU procedure
IMPORTANT!
Before approving of the patient for ultrasound ablation of uterine fibroids, planning of the treatment (the so called “simulation”) has to be carried out by the certified HIFU doctors at the “Saint Marina” HIFU – Center, Pleven, Bulgaria.
It is necessary for the planning that the patient has a current (within 1 month before the examination) MRI (magnetic resonance imaging) of the pelvis with contrast enhancing agent!
The purpose of the planning is a selection of the appropriate cases, observation of the target zones, taking the needed parameters and saving the data for the actual treatment. The accuracy of the planning ensures the desired effect.
WHAT SHOULD THE POTENTIAL PATIENT FOR HIFU ABLATION OF UTERINE FIBROIDS KNOW?
There are strict criteria for the myoma patient to be approved for HIFU treatment. However, according to over 10 years statistics almost 99% of the patients have proved to be appropriate.
During the ablation (treatment) the patient is not under general anesthesia but only sedated. It means that she is in constant verbal contact with HIFU team of specialists. It is normal to feel certain discomfort in the pelvis area while the ablation is carried out – when the pain is stronger, the patient indicates it to the doctors and they take necessary measures so that the patient feels more comfortable.
The duration of the procedure is strictly individual. Usually, it does not take more than 3 hours. The duration of the treatment depends on the size, location and intensity of the blood supply to the fibroid nodule.
As a result of the ultrasound ablation a coagulative necrosis is formed in the tumor and the symptoms gradually disappear. Typically, the size of the tumor is decreased by 1 to 3 cm per month. The treated nodule usually shrinks most intensively between the third and sixth month after the HIFU-treatment.
After HIFU-ablation the patient can experience a temporary menstrual pain. If necessary, standard painkillers could be taken.
One to three menstruation cycles after the ablation might be expected to be heavier and more prolonged.
The only limitation is abstinence from sexual contacts until 1 month after the procedure. There are no restrictions on food and movements.
The patients should not become pregnant within 6 months after HIFU-treatment. The same period is required after the conventional and laparoscopic Myomectomy.
N.B. Obligatory follow-ups are carried out by the certified HIFU-specialists in 1, 3, 6, 12 and 24 months after the procedure to evaluate the recovery of the uterus.
"In the future, no one will use a scalpel to cut the patient’s body and no one will accept an operation. This is the future of the ultrasound ablation."
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(+359) 64 90 20 33; (+359) 885 519 135
Pleven 5800 Zapadna Industrialna Zona, 6 Bulgarska Aviatsia
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